Comparing seizure treatments in glioma patients

Seizure Treatment in Glioma (STING): Comparing a Treatment Strategy with Levetiracetam Versus Treatment with Valproic Acid in Glioma Patients with a First Seizure

This study is testing which of two common seizure medications, levetiracetam or valproic acid, works better for people with glioma who have just had their first seizure.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Locations: 5 sites (Amsterdam and 4 other locations)
• Trial ID: NCT03048084 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of two commonly used anti-epileptic drugs, levetiracetam and valproic acid, in patients with glioma who have experienced their first seizure. The study is designed as a randomized controlled trial, where participants will be assigned to receive one of the two medications to determine which is more effective in reducing seizure frequency. Both drugs have similar toxicity profiles and do not interfere with chemotherapy, making them suitable for glioma patients. The trial seeks to provide evidence-based guidance for the treatment of seizures in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a histologically confirmed glioma who have experienced their first seizure within the last two weeks.

Not a fit: Patients who have previously been treated with anti-epileptic drugs or have a history of non-brain tumor related epilepsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clear recommendations for the most effective seizure treatment in glioma patients, improving their quality of life.

How similar studies have performed: While there is limited evidence directly comparing these two medications in glioma patients, similar studies in other populations have shown varying degrees of success with anti-epileptic drug comparisons.

Eligibility criteria

Inclusion Criteria:

* Histologically proven or suspected diffuse astrocytoma (Isocytrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS.
* Adult patients: ≥18 years of age
* First epileptic seizure, no longer than 2 weeks ago
* Monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization
* Willing to provide written informed consent

Exclusion Criteria:

* Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks
* History of non-brain tumor related epilepsy
* Pregnancy
* Presence of contra-indications for use of levetiracetam or valproic acid

Where this trial is running

Amsterdam and 4 other locations

• Amsterdam UMC — Amsterdam, Netherlands (Suspended)
• Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
• Leiden University Medical Center — Leiden, Netherlands (Recruiting)
• Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
• Haaglanden Medical Center — The Hague, Netherlands (Recruiting)

Study contacts

• Study coordinator: Johan AF Koekkoek, MD, PhD

Conditions Glioma